| NCT ID | NCT06702579 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Radboud University Medical Center |
| Condition | Hemophilia a |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-10-30 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-10-30 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rationale: A novel point-of-care device capable of measuring factor VIII (FVIII) activity and thrombin generation (TG) is currently under development. Utilization of this device in a home situation could potentially transform hemophilia care and improve patients' autonomy. Objective: To explore the potential consequences of home monitoring of hemostatic parameters in patients with hemophilia A Study design: Cross-sectional observational study consisting of semi-structured interviews and focus groups Study population: Approximately 10 patients treated with vitamin K antagonists engaging in self-monitoring of coagulation at home and approximately 20 patients with hemophilia A. Main study parameters/endpoints: The main outcome of this study is to assess series of interrelated themes related to the unmet needs of hemophilia patients and the envisioned potential consequences of home monitoring on these unmet needs. Secondary outcomes include: identifying key features of a home monitoring platform to be used in hemophilia care, describing the experienced consequences of implementing home self-monitoring in anticoagulation treatment, assessing the current experiences of patients with self-monitoring, and providing an overview of the burdens and unmet needs experienced by patients with hemophilia with current hemophilia care. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk associated with participation in this study is negligible. Minor patients will be included in this study only if informed consent is given by both the patient and his/her caregiver (in patients between 12-16 years old). Gathering the insights of caregivers of minor patients on the current care for hemophilia and potential consequences of home self-monitoring is vital, as their experiences and needs might differ significantly from older patients. Participating in this study does not entail direct benefits. However, patients who participate can contribute to the development of future monitoring systems, which have the potential to alleviate the current burden of their disease and treatment.
Eligibility Criteria
Patients treated with vitamin K antagonists Inclusion criteria * Aged \> 16 years * Patient using vitamin K antagonist for any indication * Registered at the "Trombosezorg dichterbij" * Self-testing INR at home for \> 3 months * A history of monitoring INR at a care facility (not self-testing) * Signed informed consent form * Able to speak and understand Dutch or English without a translator Exclusion criteria • Unwilling to consent with the study or with audio recording Hemophilia A patients Inclusion criteria * Diagnosis of congenital hemophilia A, with or without inhibitors * Receiving prophylactic treatment * Patients aged ≥ 12 years or caregivers of patients aged \< 12 years old * Signed informed consent form * Able to speak and understand Dutch or English without a translator Exclusion criteria * No diagnosis of congenital hemophilia A * Unwilling to consent with the study or with audio recording Hemophilia healthcare professionals Inclusion criteria * Hematologist, hemophilia nurse, pharmacist or healthcare provider currently involved in the care for patients with hemophilia * At least \> 3 years clinical experience in hemophilia care * Signed informed consent form * Able to speak and understand Dutch or English without a translator
Frequently Asked Questions
Who can join the NCT06702579 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Hemophilia a. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06702579 currently recruiting?
Yes, NCT06702579 is actively recruiting participants. Visit ClinicalTrials.gov or contact Radboud University Medical Center to inquire about joining.
Where is the NCT06702579 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT06702579 clinical trial?
NCT06702579 is sponsored by Radboud University Medical Center. The trial plans to enroll 30 participants.